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CDI Synbiotic Study

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ClinicalTrials.gov Identifier: NCT04012788
Recruitment Status : Recruiting
First Posted : July 9, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Andreas Munk Petersen, Hvidovre University Hospital

Brief Summary:
The investigators hypothesize that treatment with a synbiotic mixture consisting of inulin Lactobacillus rhamnosus (LGG®), Lactobacillus acidophilus (LA-5®), Lactobacillus paracasei (L. casei 431®) and Bifidobacterium lactis (BB-12®) can reduce the number of C. difficile recurrences significantly.

Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Dietary Supplement: Synbiotic mixture Other: Placebo comparator Not Applicable

Detailed Description:
Probiotics have been tested for their efficacy in preventing infection with C. difficile after antibiotic exposure. Some of the most effective probiotics tested Lactobacillus rhamnosus (LGG®), Lactobacillus acidophilus (LA-5®), Lactobacillus paracasei (L. casei 431®) and Bifidobacterium lactis (BB-12®). However, most studies have focused on prevention of the first incidence of C. difficile infection rather than prevention of re-infection with C. difficile. Recurrence rates of C. difficile infection (CDI) among hospitalized patients are 15-25% - either as relapses caused by the original organism or re-infection following treatment. The potential of probiotics in preventing re-infection is less studied in these patients. Further, prebiotics which are carbohydrates only metabolized by beneficial bacteria have gained much attention the recent years for their health benefits through stimulating growth of specific types of bacteria in the gut, and recent data from mouse studies show that the prebiotic inulin can eliminate C. difficile growth, but the use of prebiotics in relation to C. difficile elimination has yet to be proven in humans. The investigators hypothesize that treatment with a synbiotic mixture consisting of inulin Lactobacillus rhamnosus (LGG®), Lactobacillus acidophilus (LA-5®), Lactobacillus paracasei (L. casei 431®) and Bifidobacterium lactis (BB-12®) can reduce the number of C. difficile recurrences significantly.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effectiveness of a Synbiotic Mixture (Inulin, Lactobacillus Rhamnosus (LGG®), Lactobacillus Acidophilus (LA-5®), Lactobacillus Paracasei, and Bifidobacterium Lactis (BB-12®)), on Decreasing Recurrence of Clostridium Difficile Associated Diarrhea- a , Randomized, Placebo-controlled Study With 4 Weeks Intervention
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : March 1, 2021

Arm Intervention/treatment
Active Comparator: probiotic arm
inulin, 15 g Lactobacillus rhamnosus (LGG®) Lactobacillus acidophilus (LA-5®) Lactobacillus paracasei (L. casei 431®) Bifidobacterium lactis (BB-12®), Total cell counts 150 billion/day
Dietary Supplement: Synbiotic mixture
A synbiotic mixture consisting of four probiotic strains and inulin (a prebiotic)

Placebo Comparator: placebo arm
placebo powder, 15 g
Other: Placebo comparator
Placebo powder




Primary Outcome Measures :
  1. Reduced recurrence of C. difficile-associated diarrhoea (CDAD) after 8 weeks [ Time Frame: 1 year ]
    telephone questionnaire with patient at end of trial as well as examination of each patient's medical record


Secondary Outcome Measures :
  1. toxin A and B levels measured by qPCR [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed with primary CDI
  • Treatment with Vancomycin
  • Subjects over 18 years of age
  • Signed informed consent

Exclusion Criteria:

  1. Chemotherapy within two months and an absolute neutrophil count of < 1000 neutrophiles/mm3
  2. Acute leukemia
  3. Serious immunodeficiency
  4. Pancreatitis
  5. Planned or recent intraabdominal operation within a time window of 14 days
  6. Terminal disease with expected survival time < 3 month
  7. Probiotic consumption within two weeks prior enrollment
  8. Pregnant or lactating women
  9. A history of inflammatory or irritable bowel disease
  10. Colectomy and cirrhosis
  11. Septicemia
  12. Toxic megacolon

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04012788


Contacts
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Contact: Andreas M Petersen 004538626199 andreas.munk.petersen@regionh.dk
Contact: Maria IC Rubin ingrid.maria.cecilia.rubin@regionh.dk

Locations
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Denmark
Hvidovre Hospital Recruiting
Hvidovre, Denmark
Contact: Andreas M Petersen         
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
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Principal Investigator: Andreas M Petersen Gastrounit, Hvidovre Hospital

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Responsible Party: Andreas Munk Petersen, MD, Cosultant, PhD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT04012788     History of Changes
Other Study ID Numbers: H-18041764
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Andreas Munk Petersen, Hvidovre University Hospital:
probiotics
prebiotics
synbiotics

Additional relevant MeSH terms:
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Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections